Automatic oxygen therapy device

Abstract

The design and structure of a fully automatic oxygen therapy apparatus is exhibited in this disclosure. The apparatus integrates a MEMS mass flow meter, an oximeter, a proportional valve and a smart liquid bottle. The control unit of the apparatus is embedded with a wireless communication device and powered by a battery pack. This apparatus is designed to replace the mechanical oxygen rotameter used in today's hospital or homecare oxygen therapy applications. With a set recipe or parameters locally or remotely, the disclosed apparatus can perform a fully automatic oxygen therapy for recovering the blood oxygen level of patient, without the frequent attention of the therapy administrator, and especially it significantly reduces the possibility of cross infection to the administrator during the attendance of the oxygen therapy process. The therapy process data are relayed to local users as well as a designated cloud or data center. This disclosure will be beneficial for both medical staffs and patient.

1 . A fully automatic oxygen therapy apparatus having the MEMS mass flow meter to replace the existing mechanical rotameter and the integration of a proportional valve as well as an oximeter to fully control the delivery of the oxygen to patient with adjustment according to the feedback from the oximeter for human blood oxygen level. All process and data will be seamlessly relayed to the designated cloud, therapy administrator and/or data control center via wireless transmission while the apparatus will be fully granted the access to the designated and approved therapy administrator. The said apparatus is preferred to be powered by battery pack such that it can have the mobility to replace the current mechanical control unit in all applications. The said automatic oxygen therapy will be comprising:
 A MEMS gas mass flow sensing unit that provides the precise, and temperature and pressure independent measurement for the instant flowrate as well as totalized oxygen delivered during the oxygen therapy;   An oximeter utilizing the transmission infrared sensing technology for measurement of the human blood oxygen level;   A proportional oxygen compatible valve that can adjust the supply of the oxygen within the therapy allowed range;   A local control unit with accessible keyboard that can enter the therapy parameters or recall the therapy recipe; store the therapy data; drive the proportional valve and acquire the instant data from the mass flow unit and oximeter;   A wireless data communication module for remote data register as well as remote access to the said apparatus;   A local display that relays the instant oxygen therapy process information, abnormal events as well assists the parameter register via the keyboard;   A physical data port via which the oxygen therapy data including the parameters and process data can be downloaded;   A liquid bottle that serves the purpose of adding humidity to the oxygen before delivery to the patient;   A battery pack with a backup wall plug power adapter and/or rechargeable power adapter;   A complete enclosure that houses the said components for being constituent into a complete and stand-alone automatic oxygen therapy apparatus Such an enclosure will also meet the safety requirements for medical applications.   
     
     
         2 . The fully automatic oxygen therapy apparatus having the capability to precise metering and adjust the oxygen supply based on feedback from oximeter and to communicate with the remote designated administrator of  claim 1  wherein the said MEMS gas mass flow sensing unit is able to provide the precision temperature and pressure independent measurement of the oxygen delivered during the complete therapy time frame. It is preferred that the measurement is utilizing the thermal mas flow or thermal time-of-flight sensing principle such that both the flowrate and pressure can be simultaneously measured. The full scale of the oxygen mass flowrate is preferred to be adjustable and covers both high and low flowrate oxygen therapy, and the preferred values are from 15 standard liter per minutes to 120 standard liter per minutes and to the maximal of 150 standard liter per minutes. The said mass flow sensing unit is also able to measure both the instant flowrate and totalized oxygen amount. 
     
     
         3 . The fully automatic oxygen therapy apparatus having the capability to precise metering and adjust the oxygen supply based on feedback from oximeter and to communicate with the remote designated administrator of  claim 1  wherein the said oximeter is preferred to be utilizing infrared transmission sensor to measure the human blood oxygen level. The oximeter is preferred to be a stand-alone unit that can be independently certified by a third party such as the Food and Drug Administration for the use of medical measurement. The oximeter is further preferred to have the digital output interface that can communicate with the control unit of the said automatic oxygen therapy apparatus. 
     
     
         4 . The fully automatic oxygen therapy apparatus having the capability to precise metering and adjust the oxygen supply based on feedback from oximeter and to communicate with the remote designated administrator of  claim 1  wherein the said control valve is preferred to be a proportional valve with the constant open option at power failure to ensure the delivery of oxygen to patient under power failure. The said proportional valve is driven by the control unit that determines the valve openness for the optimal oxygen flowrate to be delivered to the patient based on the individual therapy requirements. Alternatively, for the constant oxygen flowrate therapy, this said proportional valve can also be replaced with a constant open opted ON/OFF valve which will be used to cut off the oxygen supply at the end of the therapy for the automation therapy purpose. 
     
     
         5 . The fully automatic oxygen therapy apparatus having the capability to precise metering and adjust the oxygen supply based on feedback from oximeter and to communicate with the remote designated administrator of  claim 4  wherein the said flowrate control will also be able to be realized manually. The manual valve will be in service in case that the electrical power failure and the proportional or the ON/OFF valve is not functional such that the therapy can still be carried out and will not lead to any medical safety issue. 
     
     
         6 . The fully automatic oxygen therapy apparatus having the capability to precise metering and adjust the oxygen supply based on feedback from oximeter and to communicate with the remote designated administrator of  claim 1  wherein the said control unit will have the capability to have the oxygen therapy parameters as well as the patient identification or other related information or complete oxygen therapy recipe being manually entered into its data storage for process retrieval. The said control unit will also take the measurement data simultaneously from the MEMS mass flow sensing units and those form the oximeter to execute the user input therapy recipe for the optimal oxygen delivery to the patient. The said control unit will further have a plurality of numbers of memory chips or devices that allows the data can be simultaneously stored for data safety. It will also have other necessary functions such as allow the user to set password for protection. 
     
     
         7 . The fully automatic oxygen therapy apparatus having the capability to precise metering and adjust the oxygen supply based on feedback from oximeter and to communicate with the remote designated administrator of  claim 1  wherein the said wireless communication capability will be able to take the remote data entry as well as to transmit the data from the said control unit wirelessly to the designated cloud or administrator or data center or designated users. For the applications in hospital ward, the preferred wireless capability is low energy LoRa wide area network that is self-support and provides the required data safety and privacy. For the applications in homecare applications, the preferred wireless communication is low energy NB-IoT protocol such that the long-distance communication can be enabled. Alternatively, for homecare applications, the said control unit is preferred to be enabled by Bluetooth LE such that it is able to directly talk to a smart device that may provide a better wireless data transmission capability over NB-IoT due to the availability of the network. The said control unit will monitor the process parameters of the pre-entered or recalled recipe and make the oxygen delivery adjustment for the optimal results, and will also store locally and send remotely any alarms, abnormal event and the complete process data. 
     
     
         8 . The fully automatic oxygen therapy apparatus having the capability to precise metering and adjust the oxygen supply based on feedback from oximeter and to communicate with the remote designated administrator of  claim 1  wherein the said local display will be able to provide all the related information including instant oxygen flowrate, accumulated delivered oxygen, blood oxygen level, therapy time, battery or power status. Additional it will also display any alarm codes, liquid level and relative humidity of the oxygen delivered. For the control unit that has the stored therapy recipe, the display will also indicate the current recipe in use. The local display will also serve as the assistance to the use of keyboard for entering the patient information, parameters and or other related information. 
     
     
         9 . The fully automatic oxygen therapy apparatus having the capability to precise metering and adjust the oxygen supply based on feedback from oximeter and to communicate with the remote designated administrator of  claim 1  wherein the said physical data port via which the oxygen therapy data including the parameters and process data can be downloaded to a physical digital data processing devices such as a laptop computer. The physical data port on the said control unit will serve as a data backup in case of failure in wireless data transmission. The pre-arranged oxygen therapy recipes can also be uploaded to the control unit via this physical data port which is preferred to be made of a Type-C USB connection that is widely available to the general public. The connection cable can also be used for external power supply or battery recharge adapter cable. Alternatively, other commonly used data port formality can also be used such as but not limited to micro-USB, mini-USB, DB9, RJ connections. 
     
     
         10 . The fully automatic oxygen therapy apparatus having the capability to precise metering and adjust the oxygen supply based on feedback from oximeter and to communicate with the remote designated administrator of  claim 1  wherein the said the liquid bottle that serves the purpose of adding humidity to the oxygen before delivery to the patient. The said liquid bottle can be in two formality. A reusable one which is directly engaged via a mechanical connection to the control unit. Another option is a pre-filled disposable medical grade liquid bottle that is connected to the control unit via a soft medical compatible pipe. The preferred option will be the disposable one that is pre-filled with medical grade water such as sterilized water. For the preferred option of the disposable liquid bottle, a level sensor such as an ultrasonic sensor is installed at the bottom of the control unit where the liquid bottle is engaged. This sensor is preferred to transmit the data via a wired connection to the control unit once the liquid level is below 3 mm above the bottom, but most preferably below 5 mm above the bottom. It is also preferably such an alarm can be programmed depending on the therapy recipe such as oxygen delivered flowrate and time. Additionally, a humidity sensor will be installed at the exit of the oxygen on the said liquid bottle. This sensor is preferred to be a stand-alone in a capsule that can be directly engaged to the exit of the oxygen in the liquid bottle, and its data transmission is also realized via wired transmission mode to the control unit. The humidity sensor will monitor the water vapor concentration in the oxygen to be delivered to patient and feedback to the oxygen flowrate that can be adjustable via the control unit. 
     
     
         11 . The fully automatic oxygen therapy apparatus having the capability to precise metering and adjust the oxygen supply based on feedback from oximeter and to communicate with the remote designated administrator of  claim 10  wherein the liquid bottle can have the function of heating with a temperature control feedback. The heating capability will allow the humidified oxygen be kept at a temperature in proximity to the human body temperature, which will provide the ultimate comfort for patient dur the complete oxygen therapy process. 
     
     
         12 . The fully automatic oxygen therapy apparatus having the capability to precise metering and adjust the oxygen supply based on feedback from oximeter and to communicate with the remote designated administrator of  claim 1  wherein the said battery pack with a backup wall plug power adapter and/or rechargeable power adapter. The battery option will allow the unit to be capable of the ultimate mobility which is important for the homecare applications where the oxygen supply is mostly by the medical oxygen gas cylinder. The mobility capability is also critical for the cases when the visiting patients are overwhelming for the hospital capacity in the pandemic situation such as the COVID-19 when the patient will be treated with the oxygen therapy from oxygen gas cylinders. 
     
     
         13 . The fully automatic oxygen therapy apparatus having the capability to precise metering and adjust the oxygen supply based on feedback from oximeter and to communicate with the remote designated administrator of  claim 1  wherein the said the complete enclosure that houses the said components for being constituent into a complete and stand-alone automatic oxygen therapy apparatus. The enclosure will meet the safety requirements for medical applications. It will be made preferably with sturdy medical compatible engineering plastics or other specific materials for the requirements of the medical environments.